Prevalence of atrial fibrillation with insertable cardiac monitors in cryptogenic stroke: A single-center experience

Asaithambi, Ganesh; Monita, Jane E; Annamalai, Muthukkaruppan; Ho, Bridget M; Marino, Emily H; Hanson, Sandra

doi:10.1016/j.jelectrocard.2018.08.033

Cited by 10 publications

(15 citation statements)

References 18 publications

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“…Nine studies tested the Reveal LINQ device, 15,[52][53][54][55][56][57][58][59] six included a mix of Reveal LINQ and XT 38,[60][61][62][63][64] and 10 studies tested only the XT device. 14,[65][66][67][68][69][70][71][72][73] One study included a mix of Reveal XT and Biotronik BioMonitor (an earlier model of the BioMonitor 2-AF), although only 13% were inserted with a BioMonitor (n = 16); 74 no studies reported using the Confirm Rx.…”

Section: Observational Studiesmentioning

confidence: 99%

“…Seventeen studies were prospective single-arm observational studies that followed patients who met predefined inclusion criteria and were implanted with an ICM after a CS during a set time frame. 38,54,56,[58][59][60][61][62][63]65,[67][68][69][70][71]73,74 Five studies collected data retrospectively from CS patients who had received an ICM 52,53,55,57,64 and one study did not report a clear methodology. 66 The EAG reiterates the inherent biases within the observational evidence due to the single-arm designs and the clinical heterogeneity identified, and encourages caution in drawing conclusions from naive comparisons between studies.…”

Section: Observational Studiesmentioning

confidence: 99%

“…Nine studies used an AF episode threshold of 2 minutes, 15,38,57,58,60,62,65,66,74 four studies used a 30-second threshold in line with the CRYSTAL-AF trial (including Choe et al, 14 which is based on the CRYSTAL-AF trial ICM population), 14,[70][71][72] two studies used shorter thresholds of 10-15 seconds 63,64 and nine studies did not state a threshold. [52][53][54][55][56]59,61,68,73 When reported, studies generally stated that standard AF detection settings were used and recordings were automatically transmitted daily. Sixteen studies described episode verification and adjudication, 14,15,38,52,54,55,57,58,60,62,65,66,[70][71][72]74 although to varying levels (e.g.…”

Section: Diagnostic Yield: Atrial Fibrillation Detection Ratementioning

confidence: 99%

“…[52][53][54][55][56]59,61,68,73 When reported, studies generally stated that standard AF detection settings were used and recordings were automatically transmitted daily. Sixteen studies described episode verification and adjudication, 14,15,38,52,54,55,57,58,60,62,65,66,[70][71][72]74 although to varying levels (e.g. by a study clinician or by two independent cardiologists).…”

Section: Diagnostic Yield: Atrial Fibrillation Detection Ratementioning

confidence: 99%

“…Seven studies 15,52,53,58,70,72,74 reported AF detection after different lengths of follow-up, which gives an indication of the rate of AF detection over time. In general, the studies indicate that a minority of patients are diagnosed within the first month (mostly in the region of 10% detected by 1 year), around 70-80% by 6 months and a small number beyond 1 year of monitoring.…”

Section: Diagnostic Yield: Atrial Fibrillation Detection Ratementioning

confidence: 99%

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Implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation

Edwards

Wakefield

Jhita

et al. 2020

Health Technol Assess

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Background Cryptogenic stroke is a stroke for which no cause is identified after standard diagnostic tests. Long-term implantable cardiac monitors may be better at diagnosing atrial fibrillation and provide an opportunity to reduce the risk of stroke recurrence with anticoagulants. Objectives The objectives were to assess the diagnostic test accuracy, clinical effectiveness and cost-effectiveness of three implantable monitors [BioMonitor 2-AF™ (Biotronik SE & Co. KG, Berlin, Germany), Confirm Rx™ (Abbott Laboratories, Lake Bluff, IL, USA) and Reveal LINQ™ (Medtronic plc, Minneapolis, MN, USA)] in patients who have had a cryptogenic stroke and for whom no atrial fibrillation is detected after 24 hours of external electrocardiographic monitoring. Data sources MEDLINE, EMBASE, The Cochrane Library, Database of Abstracts of Reviews of Effects and Health Technology Assessment databases were searched from inception until September 2018. Review methods A systematic review was undertaken. Two reviewers agreed on studies for inclusion and performed quality assessment using the Cochrane Risk of Bias 2.0 tool. Results were discussed narratively because there were insufficient data for synthesis. A two-stage de novo economic model was developed: (1) a short-term patient flow model to identify cryptogenic stroke patients who have had atrial fibrillation detected and been prescribed anticoagulation treatment (rather than remaining on antiplatelet treatment) and (2) a long-term Markov model that captured the lifetime costs and benefits of patients on either anticoagulation or antiplatelet treatment. Results One randomised controlled trial, Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL-AF) (Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med 2014;370:2478–86), was identified, and no diagnostic test accuracy study was identified. The CRYSTAL-AF trial compared the Reveal™ XT (a Reveal LINQ predecessor) (Medtronic plc) monitor with standard of care monitoring. Twenty-six single-arm observational studies for the Reveal devices were also identified. The only data for BioMonitor 2-AF or Confirm Rx were from mixed population studies supplied by the companies. Atrial fibrillation detection in the CRYSTAL-AF trial was higher with the Reveal XT than with standard monitoring at all time points. By 36 months, atrial fibrillation was detected in 19% of patients with an implantable cardiac monitor and in 2.3% of patients receiving conventional follow-up. The 26 observational studies demonstrated that, even in a cryptogenic stroke population, atrial fibrillation detection rates are highly variable and most cases are asymptomatic; therefore, they probably would not have been picked up without an implantable cardiac monitor. Device-related adverse events, such as pain and infection, were low in all studies. The de novo economic model produced incremental cost effectiveness ratios comparing implantable cardiac monitors with standard of care monitoring to detect atrial fibrillation in cryptogenic stroke patients based on data for the Reveal XT device, which can be related to Reveal LINQ. The BioMonitor 2-AF and Confirm RX were included in the analysis by making a strong assumption of equivalence with Reveal LINQ. The results indicate that implantable cardiac monitors could be considered cost-effective at a £20,000–30,000 threshold. When each device is compared incrementally, BioMonitor 2-AF dominates Reveal LINQ and Confirm RX. Limitations The cost-effectiveness analysis for implantable cardiac monitors is based on a strong assumption of clinical equivalence and should be interpreted with caution. Conclusions All three implantable cardiac monitors could be considered cost-effective at a £20,000–30,000 threshold, compared with standard of care monitoring, for cryptogenic stroke patients with no atrial fibrillation detected after 24 hours of external electrocardiographic monitoring; however, further clinical studies are required to confirm their efficacy in cryptogenic stroke patients. Study registration This study is registered as PROSPERO CRD42018109216. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 5. See the NIHR Journals Library website for further project information.

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